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Medical Devices Eu Mdr Jobs (NOW HIRING)

DEV-X Consulting LLC

EU MDR Project Manager

Exton, PA · Remote

$83K - $167K/yr

... Medical Device or Pharmaceuticals Must have a solid understanding of CERs within EU MDD MDR compliance Responsibilities * Set project timelines * Monitor project deliverables * Update relevant ...

DEV-X Consulting LLC

EU MDR Project Manager

Exton, PA · Remote

$83K - $167K/yr

... Medical Device or Pharmaceuticals Must have a solid understanding of CERs within EU MDD MDR compliance Responsibilities * Set project timelines * Monitor project deliverables * Update relevant ...

CYNET SYSTEMS

Regulatory Affairs Associate

Sylmar, CA · On-site

$40 - $45/hr

Recent experience with Class III implantable medical devices is preferred. * Exposure to authoring and/or supporting PMA supplements and familiarity with EU MDR (2017/745) requirements are desirable.

Abbott

Regulatory Affairs Associate

Lake View Terrace, CA · On-site

$40 - $46/hr

Review and approval of manufacturing and design changes for Class III implantable medical devices, including assessment of regulatory impact under both FDA and EU MDR requirements. Requires a ...

Abbott

$40 - $46/hr

Review and approval of manufacturing and design changes for Class III implantable medical devices, including assessment of regulatory impact under both FDA and EU MDR requirements. Requires a ...

Actalent

Electrical Engineer

Aurora, CO · Hybrid

$57.69/hr

... EU MDR and IEC 60601 standards. What You'll Do As an Electrical Engineer, you will: * Design, evaluate, and support electrical systems used in medical devices. * Plan, execute, and document ...

Morgan Stanley

Director, Regulatory Affairs

Littleton, CO · On-site

$177 - $266/hr

... EU MDR technical documentation). * Regulatory Affairs Certification (RAC) preferred. Technical & Clinical Knowledge * Experience with patient‑specific or additively manufactured medical devices ...

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Medical Devices Eu Mdr information

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How much do medical devices eu mdr jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for medical devices eu mdr in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What are some common challenges professionals face when ensuring medical device compliance with EU MDR regulations?

One of the main challenges in ensuring medical device compliance with EU MDR is staying up-to-date with evolving regulatory requirements and interpreting complex technical documentation standards. Professionals often need to collaborate closely with cross-functional teams, including engineering, quality assurance, and regulatory affairs, to gather comprehensive clinical evidence and maintain thorough technical files. The increased scrutiny during audits and the need for detailed post-market surveillance can also add significant workload, making strong organizational and communication skills essential for success in this role.

What is Medical Devices EU MDR?

Medical Devices EU MDR refers to the European Union Medical Device Regulation (EU MDR), which is a set of regulations that govern the production and distribution of medical devices within the European Union. The MDR (Regulation (EU) 2017/745) replaced the previous Medical Device Directive (MDD) in May 2021, introducing stricter requirements for device safety, clinical evaluation, and post-market surveillance. Compliance with EU MDR is mandatory for companies seeking to sell medical devices in the EU, ensuring a higher standard of safety and performance for patients and users. The regulation impacts manufacturers, importers, distributors, and authorized representatives involved in the EU medical device market.

What are the key skills and qualifications needed to thrive as a Medical Devices EU MDR specialist?

To thrive as a Medical Devices EU MDR Specialist, you need deep knowledge of regulatory compliance, quality management systems, and the EU Medical Device Regulation (MDR), often supported by a degree in life sciences or engineering. Familiarity with technical documentation, risk management tools, and regulatory submission systems like Eudamed is crucial. Strong attention to detail, analytical thinking, and effective communication set top professionals apart in this role. These skills ensure that medical devices meet stringent EU standards, supporting patient safety and successful market access.

What is the difference between Medical Devices Eu Mdr vs Medical Devices Regulatory Affairs Specialist?

AspectMedical Devices Eu MdrMedical Devices Regulatory Affairs Specialist
CertificationsKnowledge of EU MDR regulations, often requires specific trainingRegulatory certifications (e.g., RAC, RAPS) preferred
Work EnvironmentRegulatory compliance, quality assurance, and documentation within medical device companiesRegulatory strategy, submission preparation, and compliance across regions
Industry UsageRegulatory framework for medical devices in the EURegulatory role focusing on medical device approval and compliance

While both roles involve regulatory knowledge, Medical Devices Eu Mdr focuses specifically on ensuring medical devices meet EU MDR standards, whereas a Medical Devices Regulatory Affairs Specialist handles broader regulatory strategies across multiple regions. The MDR role is more specialized in EU compliance, while the specialist manages global regulatory submissions and strategies.

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Medical Devices Eu Mdr jobs near you
Infographic showing various Medical Devices Eu Mdr job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Design Assurance Engineer - Orthopedic Medical Devices

Stark Pharma Solutions Inc

San Francisco, CA • On-site

Contractor

Re-posted 4 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Design Assurance Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows.

Role: Design Assurance Engineer – Orthopedic Medical Devices

Location: California
Duration: Long Term

Position Overview

We are seeking an experienced Design Assurance Engineer to support EU MDR remediation and quality initiatives for orthopedic medical device product lines. This role will focus on design assurance activities, technical documentation remediation, risk management, and ensuring compliance with global regulatory requirements throughout the product lifecycle.

The ideal candidate will have a strong background in orthopedic medical devices, design controls, risk management, and EU MDR compliance within a regulated medical device environment.

Key Responsibilities

  • Support EU MDR remediation projects for orthopedic medical device products.
  • Review, update, and maintain Design History Files (DHFs) and technical documentation.
  • Perform design assurance activities across all stages of the product lifecycle.
  • Conduct risk management activities in accordance with ISO 14971 requirements.
  • Execute gap assessments and remediation efforts to ensure EU MDR compliance.
  • Participate in design reviews and support design control activities.
  • Review and update verification and validation documentation.
  • Collaborate with Regulatory Affairs, Clinical Affairs, Manufacturing, R&D, and Quality teams.
  • Support regulatory submissions and responses related to EU MDR requirements.
  • Ensure compliance with FDA regulations, EU MDR requirements, ISO 13485, and applicable quality standards.
  • Drive quality and compliance improvements across product development and remediation initiatives.

Required Qualifications

  • Bachelor's degree in Engineering or a related technical discipline.
  • 5–10+ years of Design Assurance, Quality Engineering, or Medical Device Quality experience.
  • Strong experience within the orthopedic medical device industry.
  • Proven experience supporting design assurance, remediation, or quality engineering projects.
  • Strong knowledge of:
    • Design Controls
    • Risk Management
    • Product Lifecycle Management
    • Technical Documentation
    • Design History Files (DHFs)
  • Working knowledge of:
    • FDA 21 CFR Part 820
    • ISO 13485
    • ISO 14971
    • EU MDR Regulations
  • Experience working within cross-functional product development and quality teams.
  • Excellent communication, technical writing, and documentation skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com